Record Number of FDA New Drug Approvals in 2015

A new report from Express Scripts, the largest pharmacy benefit management organization in the United States, notes that the FDA set a new record for the number of drugs approved in one year in 2015.

The review, authored by Chris Peterson, PharmD, points out that a total of 56 drugs—33 specialty and 23 traditional—got the OK from the FDA. The previous record for FDA approvals was a decade ago, in 1996, when 53 pharmaceuticals got the stamp of approval.

“Specialty drugs to treat rare conditions, as well as complex diseases such as cancer, have accounted for the majority of FDA approvals for the past five years as drug manufacturers devote more time and money to developing specialized treatments,” Peterson writes. “While the majority of drugs to gain approval in 2015 were specialty drugs, several new traditional drugs to treat heart failure present new treatment options for millions of Americans. With new treatments for heart failure and high cholesterol, as well as the first biosimilar to gain approval, 2015 was a blockbuster year for drugs to gain FDA approval.”

The articles singles out the approval in March 2015 of Zarxio (filgrastim-sndz), a biosimilar product produced by Sandoz, which competes with Amgen’s Neupogen (filgrastim), approved to decrease rates of infection in certain cancer patients during chemotherapy.

“Biosimilars have the potential to significantly lower the cost for safe and effective treatments for patients,” according to the report.

“These drugs offer additional treatment options for certain patients with high blood cholesterol and cost about $14,000 per patient annually,” states Peterson. “Numerous ongoing clinical trials are looking at their use in concert with statins. If trials show they improve cardiovascular outcomes, use of these therapies could be extensive. Anywhere from 10 million to 20 million Americans may be candidates for therapy with a PCSK9 inhibitor.”

Other breakthrough therapies were approved, many to treat orphan conditions or certain types of cancer where patients had run out of options, according to the study. Among those were:

• Ibrance (palbociclib), for the treatment of breast cancer; • Tagrisso (osimertinib) and Alecensa (alectinib), which were approved for the treatment of certain patients with non-small cell lung cancer;• Orkambi (lumacaftor and ivacaftor), for the treatment of cystic fibrosis; • Strensiq (asfotase alfa), for a rare metabolic bone disease; and • Kanuma (sebelipase alfa), for treatment for a specific enzyme deficiency.

Express Scripts also highlighted new treatments for Americans with heart failure, noting that half of the patients die within 5 years of diagnosis.

With current prescription drug therapies including diuretics, vasodilators, inotropic agents, anticoagulants, and beta-blockers, FDA last year approved Amgen’s Corlanor (ivabradine) for heart failure patients who continue to have a high heart rate despite treatment and Novartis’ Entresto (sacubitril/valsartan), classified as a blockbuster drug.